Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

Completed

• Conditions: Embolic Stroke of Undetermined Source; Ischemic Stroke

• Registration Number: NCT03107637
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Primary Completion: 2018-04
• Study Completion: 2019-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Presenting with a new onset of ischemic stroke
• Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
• Comprehensive transthoracic echo prior to the TEE

Exclusion Criteria

• ESUS criteria not met
• Contraindications to TEE
• TEE failure
• Pregnant or breastfeeding woman
• Person under legal protection
• No medical insurance coverage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
therapeutic modification after transesophageal echocardiography	24 hours after TEE	proportion of patients with a therapeutic modification (mainly anticoagulation and surgery)

Trial Locations

Locations (1)

Fondation Ophtalmologique A de Rothschild; 🇫🇷 Paris, France